Validation of Vital Signs Recording With VT-Patch Connected Devices in Children

Main objective: Assess the accuracy of VT-Patch® to measure oxygen saturation (SpO2) in children with diverse skin colour. Secondary objectives: Assess the accuracy of VT-Patch® to measure 3 additional physiologic parameters (heart rate (HR), respiratory rate (RR), and temperature. Exploratory assessment of blood pressure (BP) measurement, ECG signal, and movement capture. Design: Prospective validation study of VT-Patch® for the recording of 4 physiologic parameters and exploratory assessment of three additional parameters. Methods: The study will be performed in two successive phases: Run-in phase: Testing VT-Patch® on four children to assess the feasibility of the protocol. Main study: validation phase of the devices on 12 children per age group (2 children per skin colour group) to assess its accuracy (VT-Patch® for less than 2 years old). The patients of the run-in phase will be included in the main study if no modification of the protocol is required. 5 physiologic parameters (HR, SpO2, RR, temperature, and ECG) will be prospectively and simultaneously recorded for 8 hours with VT-Patch® and the regular monitoring system implemented in the unit High-resolution database that will be the gold standard for evaluation. Vital signs recorded with the connected device will not be used for the clinical care of patients. The Skin colour of each patient will be assessed by the colorimetric Monk scale and as shown below.